This appeared last week:
Medicare data used to recruit people with bipolar for research
By Kate Aubusson
July 29, 2019 — 12.00am
A letter sent to almost 50,000 patients prescribed lithium inviting them to take part in a bipolar study has raised questions about how Medicare stores and uses private healthcare information.
UNSW psychiatrist Professor Gordon Parker first became aware of a study investigating the genetics of bipolar when a former patient sent him an angry email accusing him of breaching her privacy.
“She was furious with me, believing that she was contacted by Medicare because I had blown her confidentiality,” he said.
But the letter had been sent by the Department of Health Services (DHS) on behalf of a research team at QIMR Berghofer Medical Research Institute inviting recipients to participate in a study exploring potential biomarkers for bipolar disorder.
“The [DHS] has sent you this letter because its records show that you may have been prescribed lithium at some time in the last five years,” the letter read.
Recipients were invited to complete an online questionnaire and, if eligible, supply a saliva sample from which the researchers would extract DNA.
The project could potentially be crucial for bipolar treatment and is reminiscent of the world-first study published last week in which an international team of researchers - including QIMR investigators - identified a number of genes linked to anorexia.
But the anorexia study's call for participants relied on a news and social media campaign.
Professor Parker said he was “gobsmacked and seriously concerned” by the recruitment method, which raised serious ethical questions.
“I had no idea [the DHS] kept such a database on people dispensed lithium, and I suspect many don’t know Medicare is holding this private, identifying data,” he said.
Fellow psychiatrist Professor Philip Boyce at the University of Sydney was also contacted by a handful of upset patients who mistakenly believed he had disclosed their private information without permission.
The letter stated in bold text that the DHS had not provided any identifying information about recipients to the researchers, and their information was protected by privacy and health legislation.
But several patients expressed anger at receiving a letter linking them to lithium and - by proxy - a psychiatric disorder they had not disclosed to anyone but their psychiatrist, GP and close family, Professor Boyce said.
Others were concerned that a housemate or their new partner could have opened the letter by mistake.
“For someone with a severe mental illness, it’s not exactly comforting to receive a letter like this,” Professor Boyce said. "It’s a fairly bold approach."
Maurice Blackburn medical negligence lawyer Tom Ballantyne said the case showed there should be greater clarity about what information is stored by government agencies and whether such recruitment methods are appropriate.
"Just because it's legal doesn't mean it's appropriate," he said.
“You can imagine that getting a letter like this could be quite confronting, and you would be very sympathetic to them,” he said, particularly in the context of recent health information data breaches, and the concerns around My Health Record.
Mr Ballantyne said the case highlighted a need for more rigorous informed consent and greater transparency from the government about the rules governing how health data is stored and used.
“But this would all need to be weighed against the really important potential benefits that can come from this type of research," he said.
The study’s lead researcher Professor Sarah Medland deeply apologised to recipients who were upset or uncomfortable about receiving the letter.
“We did not intend for there to be any upset or concern,” Professor Medland said.
More here:
There is some excellent commentary on the issue here from the Conversation.
No, it’s not OK for the government to use your prescription details to recruit you for a study
July 31, 2019 5.26pm AEST
Authors
Assistant Professor, School of Law, University of Canberra
Associate Professor of Law, Bond University
The department of human services (DHS) is under scrutiny this week after the Nine papers revealed the department sent letters to 50,000 patients who were previously prescribed lithium. DHS was seeking to recruit the recipients into a non-government study on bipolar disorder.
Psychiatrists raised concerns after receiving complaints from patients who had received the letters and accused their psychiatrists of breaching patient confidentiality.
The doctors didn’t breach confidentiality. Instead, DHS, which delivers social and health payments and services, including via Medicare, used data held by Medicare to contact patients who had previously been prescribed lithium on behalf of researchers from the QIMR Berghofer Medical Research Institute.
Patients were invited to complete an online survey, and potentially provide DNA samples, to identify genetic markers associated with bipolar disorder.
Research using big datasets is increasingly common. Big data, combined with genomics, is an extremely powerful research tool, offering tantalising opportunities to gain insight into major challenges to human health. It’s reliant on collection of data from many different individuals.
But in pursuing population-scale benefits, the risks to individual autonomy and privacy are easily overlooked – or worse, they’re disregarded.
Has the ethics framework been disregarded?
This week’s revelations highlight issues with the existing ethical and legal framework governing data access.
The National Health and Medical Research Council’s national statement governs the conduct of ethical research in Australia. It outlines the structure and approval process of human research ethics committees, and identifies issues that committees must consider when deciding whether to grant approval. That includes how researchers propose to recruit research participants.
Researchers often struggle to recruit sufficient participants to their research. Participants must agree to participate voluntarily, without coercion. For some research, recruitment may be particularly challenging. The requirements imposed on participants may be excessively onerous, inconvenient or just distasteful.
Why is DHS accessing this data?
Some people in the community are especially vulnerable to breaches of confidentiality and privacy due to social stigma. This might include people with a mental illness, sexually transmitted disease, criminal conviction or parenting order. Yet DHS may hold or access data on these vulnerable groups.
Datasets such as those overseen by DHS provide researchers with a goldmine of potential participants who can be approached more directly. In this case, they were approached by DHS itself on behalf of researchers. This decision to contact patients on behalf of the researchers is ethically and legally questionable.
While DHS does release statistical information from the various schemes it administers for research, DHS’s privacy policy states it will not release identifiable or identifying information for research unless the research has ethics committee approval, and the person consents. That restriction is fundamental to Australian privacy law and policy.
DHS hasn’t released identifiable patient data. Instead, it has used personal data collected through prescriptions to contact patients on behalf of a third party – in this case the researchers. Implicitly, its mail-out signals everyone on the list has a specific medical condition.
Problematically, DHS’s privacy policy does not indicate it will collect data for this purpose, or use collected data in this way.
It’s about respect, not convenience
Given the significance of privacy and the government’s supposed commitment to transparency, many questions remain unanswered:
Which committee granted ethics approval for the research? Did that committee have the necessary expertise in data access and privacy law to make that determination, as required under the national statement?
How did the researchers justify their choice of a recruitment strategy which necessarily compromises the reasonable expectations of patients about how, and for what purposes, their personal information will be used by DHS?
Did DHS advise the relevant ethics committee that it was an agent for the researchers? How did DHS decide to use data in this way? Who made that determination? What process did they rely on to reach that decision? Are they accountable?
Who funded the mail-out? Did DHS fund the printing and distribution of the letters from its own budget? Did the researchers pay them to do so? What effect does any commercial relationship between the researchers and the department have on the independence of the research?
Can other researchers expect comparable support from DHS in future? If not, how will DHS decide between research it deems to be of merit, and research it deems to be unworthy of its assistance? And is that its role?
DHS shouldn’t just give out your data
If DHS continues acting for researchers in this way, Australians with data contained in DHS data holdings could be inundated with requests to participate in research, resulting in disengagement and research fatigue.
DHS’s reported response when questioned by journalists was that people could opt-out of further mail-outs by emailing the department. That shifts the burden of good data governance onto consumers, rather than beneficiaries of it, for the sake of bureaucratic convenience.
The fundamental issue here is one of trust, coercion and consent. People providing their personal information to the government, to access government services including prescribed medications, are doing so through necessity, not choice. Failure to provide the information results in denial of access to the service.
For DHS to use the information provided in a way that is outside both the reasonable expectation of those providing it, and its own privacy policy, is deeply disrespectful.
Here is the link:
There is also some lively discussion pro and con on Croakey.
Debate over release of Medicare data continues *Edited to add statement from DHS*
Jennifer Doggett on: August 01, 2019
The debate over the use of Medicare data to recruit consumers for a study on bi-polar disorder continues with both consumers and experts expressing concern about the practice and calling for greater transparency from government in its management of personal health data.
In an article published in The Conversation, Bruce Baer Arnold, Assistant Professor, School of Law, University of Canberra and Wendy Bonython, Associate Professor of Law, Bond University, argued that the use of personal medical data to recruit study participants is both “ethically and legally questionable.”
Consumers have also come forward expressing their distress at receiving a letter from the government and argued that it could be particularly harmful for people in vulnerable situations, such as violent relationships.
However, there had also been support for the researchers and acknowledgement of the importance of supporting high quality studies into serious illnesses, such as bi-polar.
The Department of Human Services (DHS) has also released a statement to clarify its policy on the management of personal data and related privacy issues.
These views are summarised below.
Here is the link to the discussion:
Frankly I am inclined to agree with those who feel this whole episode has been a violation of the individual’s privacy and that recruitment should have been conducted in a different way.
I have no reason to believe the study and research is more than ethical and proper, but using data matching to identify and then mail potentially vulnerable citizens out of the blue seems a step to far and to pose unacceptable individual risk for some.
What is your perspective?
David.
6 comments:
No worries David, not like there will be a breech anytime soon involving clinical trial data and personal information. Minister Hunt security is tighter than an aged care meals budget.
Surely the Chief Medical Officer had so.e involvement / oversight given the ethics of mining a health department database!
Correct and then there is the data governance framework they developed to support stuff and the ADHA very own Data Integrity board. Obviously setup so they could do whatever they want regardless of ethics or legality
This is an inappropriate and unethical use of the PBS data. There is a doctor patient trust relationship which extends to the Pharmacist dispensing the medication. My guess is that most people with ongoing illness would be keen to help researchers find a cause or a cure. This confrontational, inappropriate approach, to a group of people who likely keep this diagnosis very private (given the stigma and discrimination that is associated), is hardly likely to encourage people to actively reach out and participate. The research study sounds like a very worthwhile endeavour, but good luck finding anyone who will participate now. Count me out.
The government's mantra across many departments, especially national security and cost saving (did someone say Robo Debt?).
The ends justify the means - and damn the consequences.
To this government "the means" include abandoning all pretense of requiring consent.
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